FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Require Nasal Spray Food Studies: Aquestive

[ Price : $8.95]

Aquestive asks FDA not to approve any nasal sprays that do not submit food effect studies as part of their application.

Amazon, Walmart Illegally Sell Chemical Peels

[ Price : $8.95]

FDA warns Amazon and Walmart they are introducing unapproved chemical peel products into interstate commerce.

FDA Denies Public Citizen Tramadol Petition

[ Price : $8.95]

Citing a lack of legal authority, FDA denies a Public Citizen 2019 petition asking it to join with the Drug Enforcement Administra...

Novartis sNDA for Scemblix Expanded Use

[ Price : $8.95]

FDA accepts for priority review a Novartis supplemental NDA for Scemblix (asciminib) for the drugs expanded use in treating newly ...

Syndax Leukemia Review Extended by FDA

[ Price : $8.95]

FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...

Colon Cancer Blood Test Approved

[ Price : $8.95]

FDA approves Guardant Healths Shield blood test for colon cancer screening in adults 45 years of age and older who are at average ...

Pharmacy Compounding Panel Renewed

[ Price : $8.95]

Federal Register notice: FDA renews its Pharmacy Compounding Advisory Committee for an additional two years.

23 No-Longer-Marketed ANDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of 23 ANDAs from multiple applicants after they notified the agency that the produ...

AstraZeneca Reports Favorable Calquence Data

[ Price : $8.95]

AstraZeneca says data from its Phase 3 AMPLIFY trial showed that Calquence (acalabrutinib) in combination with venetoclax showed f...

Kaleo Social Media Post Runs Afoul of FDA

[ Price : $8.95]

FDA cites a Kaleo social media post about Auvi-Q (epinephrine injection) because it presented benefit information but failed to in...